(14 days)
The Daylite Xenon Light Source is indicated for use in surgery and medical applications where high intensity illumination is required
The Daylite XeNon Light Sources are comprised of high intensity xenon light sources, fiberoptic cables and fiberoptic headsets. The Designs for Vision Daylite Light Sources are supplied with headsets that were first placed into service prior to 1976 and are preamendment devices. The Designs for Vision headsets have been marketed since the early 1970's with a long history of safe use in the surgical suite. The headsets are either coaxial, bifurcated, or focusable designs. The light source includes a universal chuck for fiberoptic cable attachment. The universal chuck accepts various sizes of light cables. The XeNon Light sources provide either 180-watt or 300-watt power output and contain a continuous illumination level adjustment which provides 6000°K color temperature light.
The provided document K013880 is a 510(k) summary for the Designs for Vision, Inc. Daylite XeNon Light Sources. This document is a premarket notification for a medical device and describes its substantial equivalence to predicate devices, focusing on regulatory compliance rather than extensive clinical performance studies.
Therefore, many of the requested details about acceptance criteria, detailed study design, and ground truth establishment are not typically found in such a regulatory submission. A 510(k) primarily demonstrates that the new device is as safe and effective as a legally marketed predicate device.
Based on the provided text, here is the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of explicit acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating electrical safety characteristics and substantial equivalence to predicate devices.
| Acceptance Criteria (Inferred from 510(k) requirements) | Reported Device Performance |
|---|---|
| Electrical Safety (Implicit requirement for medical devices) | "Testing has been performed which demonstrates the electrical safety characteristics of the Designs for Vision, Inc. Daylite XeNon Light Sources." |
| Same Intended Use as predicate devices | "The Daylite Xenon Light Source devices have the same intended use as the predicate device..." (Indicated for use in surgery and medical applications where high intensity illumination is required.) |
| Similar Technological Characteristics to predicate devices | "...and similar technological characteristics. They all consist of Xenon Light Sources supplying fiberoptic illuminators with illumination for headlights." |
| Preamendment Status of Headsets (Implicit acceptance of existing technology) | "The Designs for Vision headsets were first placed into service prior to 1976 and are preamendment devices... a long history of safe use in the surgical suite." |
| Power Output: 180-watt or 300-watt (Characteristic, not a performance target against a criterion) | Provides either 180-watt or 300-watt power output. |
| Illumination Level Adjustment: Continuous (Characteristic) | Contains a continuous illumination level adjustment. |
| Color Temperature: 6000°K (Characteristic) | Provides 6000°K color temperature light. |
| Universal Chuck for Cable Attachment: Accepts various sizes (Characteristic) | Includes a universal chuck for fiberoptic cable attachment, accepting various sizes of light cables. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Testing has been performed which demonstrates the electrical safety characteristics." However, it does not specify a sample size or data provenance (e.g., country of origin, retrospective/prospective) for any test set. This type of detail is usually found in detailed test reports, not the 510(k) summary itself. The testing mentioned would likely involve a limited number of manufactured units to verify electrical safety standards rather than a clinical trial with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This device is a light source, not a diagnostic or AI-driven decision support system that requires expert-established ground truth from clinical cases. The "testing" referred to is against engineering and safety standards (e.g., electrical safety), not medical interpretation.
4. Adjudication Method for the Test Set
Not applicable. As the testing relates to electrical safety and compliance with existing standards for medical devices, there would not be an "adjudication method" in the sense of resolving discrepancies in expert interpretation of clinical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI algorithms where human reader performance is being evaluated or augmented. The Daylite XeNon Light Source is an illumination device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware medical device (a light source), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for this device would be its adherence to established electrical safety standards and its functional specifications (e.g., power output, color temperature, continuous illumination adjustment) as compared to its own design specifications and general medical device requirements. These are engineering and performance specifications, not clinical outcomes or expert consensus on medical findings.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware light source, not a machine learning model or AI system that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for a machine learning model, there is no ground truth established for it in this context.
{0}------------------------------------------------
K013880
Page 1 of 2
DEC 0 7 2001
510(k) Summary for Designs for Vision, Inc. Daylite Light Sources
SPONSOR 1.
Designs for Vision, Inc. 760 Koehler Avenue Ronkonkoma, NY 11779
Amy Grumet-Avallone Contact Person: (631) 585-3300 Telephone:
November 1, 2001 Date Prepared:
DEVICE NAME 2.
Daylite XeNon Light Sources Proprietary Name: Common/Usual Name: Surgical Lights Surgical Lights/Routine Fiberoptic Lights Classification Name:
PREDICATE DEVICES 3.
Walter Lorenz Surgical Inc. Lumenon Xenon Light Source K992050 K980281 Welch Allyn, Inc. Xenon 300 Light Source
DEVICE DESCRIPTION 4.
The Daylite XeNon Light Sources are comprised of high intensity xenon light sources, fiberoptic cables and fiberoptic headsets. The Designs for Vision Daylite Light Sources are supplied with headsets that were first placed into service prior to 1976 and are preamendment devices. The Designs for Vision headsets have been marketed since the early 1970's with a long history of safe use in the surgical suite. The headsets are either coaxial, bifurcated, or focusable designs.
{1}------------------------------------------------
K013880
Page 2 of 2
The light source includes a universal chuck for fiberoptic cable attachment. The universal chuck accepts various sizes of light cables. The XeNon Light sources provide either 180-watt or 300-watt power output and contain a continuous illumination level adjustment which provides 6000°K color temperature light.
ર. INTENDED USE
·The Designs for Vision Daylite Light Sources are indicated for use in surgery and medical applications where high intensity illumination is required.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The Daylite Xenon Light Source devices have the same intended use as the predicate device and similar technological characteristics. They all consist of Xenon Light Sources supplying fiberoptic illuminators with illumination for headlights.
PERFORMANCE TESTING 7.
Testing has been performed which demonstrates the electrical safety characteristics of the Designs for Vision, Inc. Daylite XeNon Light Sources.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird, both rendered in a simple, flowing line style.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 7 2001
Designs for Vision, Inc. c/o Mr. Donald James Sherratt Medical Stream Director Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719
Re: K013880
Trade/Device Name: DayLite XeNon Light Sources Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codes: 78 GCT Dated: November 21, 2001 Received: November 23, 2001
Dear Mr. Sherratt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed noutication. The I Dri miaing of basion for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please IT you desire specific advice for your ae of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on and please note the regulation entitled, "Misbranding Office of Compilance at (301) 67 - 105 (21 CFR Part 807.97). Other general information on by reletence to premation (on the Act may be obtained from the Division of Small Manufacturers, your responsibilities and Consumer & For toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
510(k) Number (if known):
Device Name: Designs for Vision, Inc. Daylite XeNon Light Sources
Indications For Use:
The Daylite Xenon Light Source is indicated for use in surgery and medical applications where high intensity illumination is required
(Please do not write below this line - continue on another page if necessary)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel le. Benjam
Prescription Use V (Per 21 CFR 801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.